The European Union's antitrust enforcer hit Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) with a 463 million-euro ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to entering the market. 31 October 2024
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Bristol Myers Squibb has scored a major legal victory as a judge in New York dismissed a $6.4 billion lawsuit related to its acquisition of cancer company Celgene. 5 October 2024
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Liquidia Corporation announced Thursday that it has filed litigation in the US District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the US Food and Drug Administration (FDA) to grant three-year new clinical investigation (NCI) exclusivity to Tyvaso (treprostinil) DPI.9.6. 23 August 2024
Netherlands-based Mylan has reached an agreement with the US Department of Justice finalizing the previously announced Medicaid drug rebate settlement of $465 million. 17 August 2017
Zydus Pharmaceuticals, an American generics company and subsidiary of Cadila Healthcare, has settled litigation with privately-held Aptalis Pharma related to the ulcerative colitis treatment Canasa. 14 August 2017
Japanese drug major Chugai Pharmaceutical today announced that an arbitration against Chugai has been commenced by the UK’s Medical Research Council and LifeArc (formerly, Medical Research Council Technology). 10 August 2017
The Russian government is considering legalizing the parallel importation of drugs into the country in an attempt to force foreign producers to reduce the prices for their range in Russia. 9 August 2017
Yungjoon Kwon, Korean patent/trademark attorney and managing director at law firm Kwon & Kim, introduces general practice and case laws related to medical use claim in South Korea in an Expert View piece. 8 August 2017
Martin Shkreli has been convicted on three of eight counts in a month-long securities fraud trial at the US District Court in Brooklyn, New York. 7 August 2017
Japanese pharma major Daiichi Sankyo (TYO: 4568) and its US subsidiary have agreed to enter into a program to settle, on behalf of all defendants, pending product liability litigation against various Daiichi Sankyo and Forest entities. 2 August 2017
In testimony presented to the U.S. House of Representatives’ Judiciary Committee Subcommittee on Regulatory Reform, Commerical and Antitrust Law, the USA’s Federal Trade Commission described its efforts to stop anticompetitive conduct in the pharmaceutical industry. 31 July 2017
US biotech firm Celgene has reached a civil settlement with relator Beverly Brown, the Department of Justice, 28 States, the District of Columbia, and the City of Chicago to resolve the previously-disclosed False Claims Act litigation pending in the US District Court for the Central District of California. 26 July 2017
AbbVie has been ordered to pay $150 million to a patient who claimed that the US drugmaker hid the risks of its AndroGel testosterone booster in aggressive advertising campaigns. 25 July 2017
All parts of the pharmaceutical industry in Hungary have come together to prevent falsified medicinal products from getting into the supply chain. 24 July 2017
Baxter International and Claris Lifesciences Limited have agreed to divest two types of pharmaceutical products to settle Federal Trade Commission charges that Baxter’s proposed $625 million acquisition of Claris Injectables business of the Indian parent company is anticompetitive. 21 July 2017
The European Commission has informed Israeli generics giant Teva Pharmaceutical Industries of its preliminary view that an agreement concluded with Cephalon was in breach of European Union antitrust rules. 18 July 2017
CSL Limited says it has become aware that Bioverativ has filed complaints in the US District Court for the District of Delaware and with the International Trade Commission. 17 July 2017
The USA’s Federal Trade Commission has approved a sub-license submitted by UK-incorporated Mallinckrodt, granting West Therapeutic Development certain rights to develop and market the specialty drug Synacthen Depot (tetracosactide) in the USA. 17 July 2017
US RNAi therapeutics company Alnylam Pharmaceuticals last week announced that, along with Sanofi Genzyme, it was starting a Phase III program investigating the use of fitusiran in patients with hemophilia A and B with or without inhibitors. 10 July 2017
The UK Supreme Court has decided in the litigation relating to alternative salt forms of Alimta (pemetrexed disodium) that Actavis' products directly infringe US pharma major Eli Lilly's vitamin regimen patents in the UK, France, Italy and Spain. 7 July 2017
The European Commission has sent three separate Statements of Objections to Germany’s Merck KGaA and its subsidiary Sigma-Aldrich, General Electric and Canon alleging they breached EU merger rules. 6 July 2017